PI Brief Update

Short Notes on Migrated Contraceptive Devices - Dr Mark Burgin

10/03/20. Dr. Mark Burgin BM BCh (oxon) MRCGP considers the elements that should be included in a primer for clinical negligence cases involving migrated contraceptive devices.

There are two types of contraceptive devices inserted by GPs that end up where they are not supposed to be – the Coil and the Implant.

Whilst one is placed in the uterus and the other the upper inner arm they have similarities – insertion is technically demanding, location and removal can be expensive.

The classic explanation for becoming misplaced is ‘migration’ where rather implausibly the device passes through the body tissues.

As with any surgical procedure the GP who inserted the device holds all the cards as they wrote the contemporaneous records but additionally the problem is recognised years later.

Mathematics

The fact of a device in the wrong place is not evidence that the insertion was negligent because doctors cannot guarantee a good result.

To show that on balance the insertion was negligent the GP’s rate of migration must be twice the average which means that the expert must do some Maths.

From the total number of prescriptions for the device and the total number of referrals for removal of migrated devices an estimate can be made of the average rate.

The practice figures are available online or from the CCG under a FOI and comparing one set of figures statistically with the other can identify a problem with the practice.

Training records

Where a single practitioner performs all the insertions of that device in the practice then no further investigation may be required to show on balance that there is a problem locally.

The material training records to show competence are the GPs log of minor surgery, training for contraceptive device insertion and CPD to keep up to date.

For a GP who performs minor surgery regularly (more than 5 a month) this is not an onerous requirement but some will find the task difficult.

There is no range of opinion whether GPs should follow the GMC advice about being competent and keeping professional knowledge and skills up to date.

Manufacturer’s guidance

The manufacturer’s guidance on implant states that the GP must palpate the implant in the arm to check that it is in the correct place.

For coils a similar approach is to check the threads at a follow up appointment after the next period to ensure that the device is present.

Failure to make these checks can lead to a delay in diagnosis of a misplaced or not inserted device and loss of a chance to take early steps to rectify the mistake.

Whilst much of the manufacturer’s guidance could be subject to a range of opinion it is unlikely that the courts will find simple checks disproportionate or unnecessary.

Conclusions

The cards are stacked against the claimant in Migrated Contraceptive Devices cases because there is a non negligent explanation for migration.

If the migration is the only evidence that a mistake was made the case will fail so it is essential make a FOI request for the numbers of prescriptions and referrals for removal of the device.

The training records can confirm that the defendant is competent keeping their professional knowledge and skills up to date.

Failure to detect a misplaced device however is more straightforward and can be based upon an analysis of the medical records and the manufacturer’s guidance.

Doctor Mark Burgin, BM BCh (oxon) MRCGP is on the General Practitioner Specialist Register.

Dr. Burgin can be contacted This email address is being protected from spambots. You need JavaScript enabled to view it. and 0845 331 3304 website drmarkburgin.co.uk

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